1. Technical Field
The present disclosure generally relates to the biopsy devices, and more particularly, needle biopsy devices for collecting tissue, fluid, and cell samples in conjunction with procedures such as endoscopic ultrasound or endoscopic bronchial ultrasound.
2. Background of the Invention
Endoscopic ultrasounds have been used for more than twenty five years within the field of medicine. These procedures allow clinicians to scan, locate and identify individual layers of the gastrointestinal (GI) tract and determine the location of individual mucosal and submucosal layers. As a result, appropriate therapeutic modes of treatment for malignancies and various abnormalities may be determined.
An endoscopic ultrasound procedure consist of several steps. First, a clinician sedates a patient and inserts a probe via esophagogastroduodenoscopy into the patient's stomach and duodenum. Second, an endoscope is passed through the patient's mouth and advanced to the level of the duodenum. Third, from various positions between the esophagus and duodenum, organs or masses outside the gastrointestinal tract are imaged to determine abnormalities. Fourth, organs or masses can be biopsed through the process of “fine needle aspiration” (FNA) if any abnormalities are present.
Endoscopic ultrasounds and endoscopic bronchial ultrasounds through fine needle aspiration are presently the standard modes of treatment in the field of gastrointestinal endoscopy and bronchoscopy. These procedures traditionally result in high yields of sensitivity and specificity in the management of indications of diseases such as esophageal cancer, pancreatic cancer, liver mass, non-small cell lung cancer, pancreatic mass, endobronchial mass, and intra-abdominal lymph nodes.
An endoscopic ultrasound through fine needle aspiration requires a device that is attached to the luer port or working channel of a typical echoendoscope. Prior art devices utilize a series of push and pull handles to control the axial movement of the catheter shaft of the device and the depth of needle penetration. These devices, however, suffer from several drawbacks.
First, the means of attaching a device to an echoendoscope is cumbersome. For example, these devices presently utilize male fitting adapters that must be screwed onto a female luer port of an endoscope. Second, prior art devices provide sub-optimal ergonomics of use. More specifically, a clinician must actuate a number of handles independently and lock respective handles in position via cap screw arrangement to secure the device. The cumulative actions required by a clinician result in significantly drawn out procedures. Third, needles commonly kink or deform during removal from a device causing numerous delays and failures. Fourth, multiple passes per procedure are required, which prolong the procedure and result in a clinician needing to reconfirm the location of a needle relative to a desired aspiration site with each new pass.
Additionally, prior art devices are not designed to individually accommodate needles of various diameters. Specifically, a device must be removed from an endoscope during a procedure if a clinician chooses to utilize multiple needle sizes. For example, a clinician may begin an endoscopic ultrasound procedure with: 1) a device having a needle with a diameter of 19 AWG; 2.) aspirate; 3.) remove the needle housing member from the device; 4.) remove the device from the endoscope; 5.) attach a new device to the endoscope and insert a needle having a diameter of 22 AWG; and 6.) track the needle through the device's sheath lumen and continue the procedure. In this instance, absent removing the device from an endoscope, the difference in the clearance between the inner diameter of the sheath and the outer diameter of the needle will increase when moving from a large needle to a smaller needle. As a result, instability in the ability of the needle to puncture a desired lesion or cyst can result causing increased manipulation time for the clinician and loss of procedural efficiency.
Therefore, a need exists for an improved device for use in endoscopic ultrasound procedures.